征求意见稿draft.docx

1、征求意见稿draft征求意见稿draft【篇一：who数据与记录管理规范指南 征求意见稿】 guidance on good data and record management practices draft for comment en 2015/09 pdf原文地址 working document qas/15.624 should you have any comments on the attached text, please send these to dr s. kopp, group lead, medicines quality assurance, technologi

2、es, standards and norms ( koppswho.int ) with a copy to ms marie gaspard ( gaspardmwho.int ) by 30 november 2015 . medicines quality assurance working documents will be sent out electronically only and will also be placed on the medicines website for comment under “current projects”. if you do not a

3、lready receive our draft working documents please let us have your email address (to bonnywwho.int ) and we will add it to our electronic mailing list. schedule for the proposed adoption process of document qas/15.624: guidance on good data and record management practicesbackground during an informa

4、l consultation on inspection, good manufacturing practices and risk management guidance in medicines manufacturing held by the world health organization (who) in geneva in april 2014 a proposal for new guidance on good data management was discussed and recommended to be developed. the participants i

5、ncluded national inspectors and specialists in the various agenda topics, as well as staff of the prequalification team (pqt)inspections. the who expert committee on specifications for pharmaceuticals preparations received feedback from this informal consultation during its 49th meeting held in octo

6、ber 2014. a concept paper was received from pqtinspections for a proposed structure of a new guidance document which was discussed in detail. the concept paper consolidated existing normative principles and gave some illustrative examples on their implementation. in the appendix to the concept paper

7、 extracts from existing good practices and guidance documents were combined to illustrate the current relevant guidance on assuring the reliability of data and related gxp matters. in view of the increasing number of observations made during inspections regarding data management practices the commit

8、tee endorsed the proposal.following this endorsement, a draft document was prepared by the colleagues from pqt- inspection and a drafting group, including national inspectors. this draft was discussed at a consultation on data management, bioequivalence, good manufacturing practices and medicines in

9、spection held 29 june1 july 2015. a revised draft document was subsequently prepared by the authors, the drafting group, based on the feedback received during this consultation and the subsequent who workshop on data management. collaboration is being sort with other organizations towards future con

10、vergence in this area. this first draft is presented herewith for comments. 1. introduction and background medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. impl

11、icit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. data on which these decisions are based should therefore be complete as well as bein

12、g accurate, legible, contemporaneous, original and attributable ; commonly referred to as “alcoa”. these basic alcoa principles and the related good practice expectations that assure data reliability are not new. much high- and mid-level normative guidance already【篇二：混凝土结构工程施工规范征求意见稿(最终稿)】 请将你们发现的本规

13、范中有关专利的内容和支持性文件随意见一并返回。 中华人民共和国国家标准 national standard of p. r. china 混凝土结构工程施工规范 code for construction of concrete structures （征求意见稿） (draft for comments) 二九年五月国家标准混凝土结构工程施工规范编制组声明 1本规范（征求意见稿）著作权为住房和城乡建设部所有。本规范尚未正式发布，任何单位不得以任何形式出版发行。任何单位或个人以经营为目的，以各种形式复制本规范（征求意见稿）的任何部分，必须事先征得国家标准混凝土结构工程施工规范编制组（以下简称本

14、规范编制组）的书面同意。任何单位或个人将本规范（征求意见稿）的任何部分上传至网络用于传播，必须事先征得本规范编制组的书面同意。 2本规范编制组原则上不反对本规范中含有专利，但该专利应是本规范中难以替代的技术，且不存在其他拒绝涉及该专利的实质性理由。此处所称专利是指依据中华人民共和国专利法获得授权且处于保护期内的发明创造。 本规范（征求意见稿）的内容不涉及任何参与本规范编制的组织或个人的专利。本规范（征求意见稿）编制过程中，本规范编制组尚未识别出涉及专利的内容。参与本规范编制的组织或个人知晓如下义务：对其所知悉的相关专利，应及时向本规范编制组提供专利信息及相应的证明材料。 若认为本规范（征求意见

15、稿）的某些内容可能涉及专利（含处于专利申请阶段尚未获得授权的发明创造），请将本规范中有关专利的内容和支持性文件送达本规范编制组。本规范编制组将请专利权利人做出书面的专利实施许可声明。本规范编制组不对本规范（征求意见稿）所涉及专利的真实性、有效性、合法性进行鉴别。 本规范编制组联系方式： 100013，中国建筑科学研究院标准规范研究中心 电话/传真：010-* 3本规范（征求意见稿）仅作为交流、讨论、修改用，不应作为混凝土结构工程设计和施工依据。 国家标准混凝土结构工程施工规范编制组 二九年五月前 言 本规范根据建设部建标2007125号（关于印发2007年工程建设标准规范制订、修订计划（第一批

16、）的通知）的要求，由中国建筑科学研究院会同有关单位编制而成。 本规范是混凝土结构工程施工的通用标准，提出了混凝土结构工程施工管理和过程控制的基本要求，并作为制修订相关专用标准的依据。本规范在控制施工质量的同时，为贯彻执行国家技术经济政策，反映建筑领域可持续发展理念，加强了节能、节地、节水、节材与环境保护等要求。本规范积极采用了新技术、新工艺、新材料。 在编制过程中，总结了近年来我国混凝土结构工程施工的实践经验和研究成果，借鉴了有关国际和国外先进标准，开展了多项专题研究，广泛地征求了有关方面的意见，对具体内容进行了反复讨论、协调和修改，并经审查定稿。 本规范的主要内容有：总则，术语，基本规定，模

17、板工程，钢筋工程，预应力工程，混凝土制备与运输，现浇结构工程，装配式结构工程，冬期、高温和雨期施工，环境保护，附录。 本规范以黑体字标志的条文为强制性条文，必须严格执行。 本规范主编单位：中国建筑科学研究院 本规范参编单位：中国建筑第八工程局、浙江华威建材集团有限公司、柳州欧维姆机械股份有限公司、黑龙江省寒地建筑科学研究院、浙江省长城建设集团股份有限公司、中国建筑第二工程局有限公司、中建一局（集团）公司、沛丰建筑工程（上海）有限公司、广州市裕丰控股股份有限公司、北京市建设监理协会、青建集团股份公司、瑞安房地产发展有限公司、华中科技大学、同济大学、中冶集团建筑研究总院、中国中铁建工集团、东南大学

18、、西卡中国集团、上海建工（集团）总公司、北京榆构有限公司、北京东方建宇混凝土科学技术研究院目 录 1 总则 . 1 2 术语 . 3 3 基本规定 . 6 3.1 施工管理 . 6 3.2 施工技术 . 8 3.3 施工质量与安全 . 9 4 模板工程 . 13 4.1 一般规定 . 13 4.2 材料 . 14 4.3 设计 . 15 4.4 安装 . 21 4.5 拆除和维护 . 25 4.6 质量检查 . 27 5 钢筋工程 . 29 5.1 一般规定 . 29 5.2 材料 . 30 5.3 钢筋加工 . 31 5.4 钢筋连接与安装 . 33 5.5 质量检查 . 39 6 预应力工程 . 42 6.1 一般规定 . 42 6.2 材料 . 43 6.3 制作与安装 . 47 6.4 张拉和放张 . 55 6.5 灌浆及封锚 . 60 6.6 质量检查 . 64 7 混凝土制备与运输 . 66 7.1 一般规定 . 66 7.2 原材料 . 67 7.3 混凝土配合比 . 72 7.4 混凝土搅拌 . 77 7.5 混凝土运输 . 79 7.6 质量检查 . 80 8 现浇结构工程 . 83 8.1 一般规定 . 83 8.2 混凝土输送 . 84 8.3 混凝土浇筑 .